Guselkumab for Psoriatic Arthritis

(SOLSTICE Trial)

Recruiting at 220 trial locations

Overseen By Study Contact

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Janssen Research & Development, LLC

Must not be taking: JAK inhibitors, Immunosuppressants

Disqualifiers: Rheumatoid arthritis, Lupus, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

453 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to evaluate the efficacy of guselkumab treatment in participants with active psoriatic arthritis (PsA) and inadequate response (IR) and/or intolerance to a prior anti-tumor necrosis factor (TNF) by assessing the reduction in signs and symptoms of PsA.

Will I have to stop taking my current medications?

The trial requires that you stop taking any systemic immunosuppressants (medications that lower the immune system's activity) at least 4 weeks before starting the study. Other medications are not specifically mentioned, so it's best to discuss with the trial team.

What data supports the effectiveness of the drug Guselkumab for treating psoriatic arthritis?

Guselkumab has shown effectiveness in treating psoriatic arthritis, as it was evaluated in studies where it improved symptoms like enthesitis (inflammation where tendons or ligaments attach to bone) and dactylitis (swelling of fingers or toes). It is also effective for moderate-to-severe plaque psoriasis, which is related to psoriatic arthritis, suggesting potential benefits for this condition as well. ^{1 2 3 4 5}

Is Guselkumab safe for humans?

Guselkumab has been generally well tolerated in studies for conditions like plaque psoriasis and psoriatic arthritis, with safety data pooled from multiple studies showing it is safe for up to 2 years of use. ^{1 2 3 6 7}

How is the drug Guselkumab unique for treating psoriatic arthritis?

Guselkumab is unique because it is the first drug to selectively block interleukin-23 (IL-23) by targeting its p19 subunit, which is different from other treatments that may target different pathways. It is administered through a subcutaneous injection and has shown effectiveness in patients who did not respond well to other treatments like tumor necrosis factor inhibitors. ^{1 2 3 8 9}

Research Team

Janssen Research & Development, LLC Clinical Trial

Principal Investigator

Janssen Research & Development, LLC

Eligibility Criteria

This trial is for people with active psoriatic arthritis who haven't responded well to or can't tolerate a previous anti-TNF alpha treatment. They should have had PsA for at least 6 months, meet specific criteria, and show certain symptoms like swollen/tender joints and elevated CRP levels.

Inclusion Criteria

I have active psoriasis with a plaque of 2cm or larger, nail changes, or a history of plaque psoriasis.

I have active psoriasis with a plaque of 2cm or larger, nail changes, or a history of plaque psoriasis.

I have been diagnosed with psoriatic arthritis for at least 6 months.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

Up to 6 weeks

Blinded Treatment

Participants receive either guselkumab or placebo subcutaneously during a placebo-controlled period

24 weeks

Regular visits for treatment and monitoring

Active-controlled Treatment

Participants receive guselkumab subcutaneously during an active-controlled treatment phase

76 weeks

Regular visits for treatment and monitoring

Safety Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Treatment Details

Interventions

• Guselkumab

Trial Overview The study tests the effectiveness of guselkumab in reducing symptoms of PsA compared to a placebo in those who didn’t respond to prior TNF blockers. Participants will be randomly assigned to receive either guselkumab or a placebo.

Participant Groups

Group I: Group 3: Placebo Followed by Guselkumab Experimental Treatment 2 Interventions

Participants will receive placebo SC and will cross over to receive guselkumab SC.

Group II: Group 2: Guselkumab Experimental Treatment 1 Intervention

Participants will receive guselkumab SC.

Group III: Group 1: Guselkumab and Placebo Experimental Treatment 2 Interventions

Participants will receive guselkumab and placebo subcutaneously (SC) to maintain the blind.

Guselkumab is already approved in United States, European Union for the following indications:

Approved in United States as Tremfya for:

• Moderate to severe plaque psoriasis
• Psoriatic arthritis
• Moderately to severely active ulcerative colitis

Approved in European Union as Tremfya for:

• Moderate to severe plaque psoriasis
• Psoriatic arthritis
• Moderately to severely active ulcerative colitis

Who Is Running the Clinical Trial?

Janssen Research & Development, LLC

Lead Sponsor

Trials

1,022

Recruited

6,408,000+

Giacomo Salvadore

Janssen Research & Development, LLC

Chief Medical Officer since 2023

MD from the University of Rome, Tor Vergata

Ricardo Attar

Janssen Research & Development, LLC

Chief Executive Officer since 2008

PhD in Molecular Biology from the University of Buenos Aires

Findings from Research

Guselkumab is an approved treatment for moderate-to-severe plaque psoriasis, specifically designed to inhibit interleukin 23 (IL-23), which plays a key role in the inflammatory process of the disease.

By blocking IL-23 from binding to its receptor, guselkumab disrupts the IL-17 pathway, which is crucial for the activation of type 17 helper T cells, thereby reducing inflammation and symptoms in patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Guselkumab: First Global Approval. Markham, A.[2019]

Guselkumab is an effective treatment for moderate to severe plaque psoriasis, showing superior results compared to placebo and adalimumab in the VOYAGE trials, with benefits maintained for up to 2 years.

Patients who previously did not respond well to ustekinumab showed significantly better outcomes when switched to guselkumab, indicating its efficacy in treatment-resistant cases, while also improving overall quality of life and being well tolerated.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Guselkumab: A Review in Moderate to Severe Plaque Psoriasis. Al-Salama, ZT., Scott, LJ.[2019]

In a phase 2a trial involving 149 patients with active psoriatic arthritis, guselkumab significantly improved symptoms, with 58% of patients achieving at least a 20% improvement in their condition compared to only 35% in the placebo group, demonstrating its efficacy as a treatment.

Guselkumab was well tolerated over 44 weeks, with a similar rate of adverse events (36% in the treatment group vs. 33% in the placebo group), indicating a favorable safety profile for this novel therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of guselkumab in patients with active psoriatic arthritis: a randomised, double-blind, placebo-controlled, phase 2 study. Deodhar, A., Gottlieb, AB., Boehncke, WH., et al.[2020]

In a study of 285 adults with psoriatic arthritis who had previously not responded to tumor necrosis factor inhibitors, guselkumab significantly improved joint symptoms, with 44.4% of patients achieving a 20% improvement in their condition (ACR20) compared to 19.8% in the placebo group at week 24.

Guselkumab demonstrated a favorable safety profile, with low rates of serious adverse events (3.7%) and no deaths or opportunistic infections reported, indicating it is a safe treatment option for patients with TNFi-resistant psoriatic arthritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of guselkumab in patients with active psoriatic arthritis who are inadequate responders to tumour necrosis factor inhibitors: results through one year of a phase IIIb, randomised, controlled study (COSMOS). Coates, LC., Gossec, L., Theander, E., et al.[2022]

In a phase II trial involving 149 patients with active psoriatic arthritis, guselkumab significantly improved symptoms of enthesitis and dactylitis compared to placebo, with these improvements sustained through week 56.

Patients who switched from placebo to guselkumab treatment experienced similar benefits in enthesitis and dactylitis as those who received guselkumab from the start, indicating its effectiveness regardless of when treatment began.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of guselkumab, an interleukin-23 p19 subunit inhibitor, on enthesitis and dactylitis in patients with moderate to severe psoriatic arthritis: results from a randomised, placebo-controlled, phase II study. Mease, PJ., Gladman, DD., Deodhar, A., et al.[2021]

Guselkumab (GUS) demonstrated a favorable safety profile in patients with psoriatic arthritis (PsA), showing low adverse event (AE) rates for both TNFi-naïve (139.7/100 patient-years) and TNFi-experienced patients (174.0/100 patient-years) over a period of up to 2 years.

The safety outcomes, including rates of serious AEs and treatment discontinuation, were consistent between GUS-treated patients and those receiving placebo, indicating that GUS is a safe treatment option for PsA regardless of prior TNFi use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of Guselkumab With and Without Prior Tumor Necrosis Factor Inhibitor Treatment: Pooled Results Across 4 Studies in Patients With Psoriatic Arthritis. Rahman, P., Boehncke, WH., Mease, PJ., et al.[2023]

In the DISCOVER-2 trial, guselkumab was tested in biologic-naive patients with active psoriatic arthritis, demonstrating significant efficacy in reducing disease activity compared to placebo.

The study's double-blind, randomized, placebo-controlled design ensures robust results, highlighting guselkumab as a promising treatment option for patients who have not previously received biologic therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Guselkumab safely improved clinical outcomes in biologic-naive patients with psoriatic arthritis. Schattner, A.[2020]

Guselkumab is a human monoclonal antibody that selectively blocks IL-23, which is important in the development of psoriasis and psoriatic arthritis, and it was approved for treating active psoriatic arthritis based on data from two phase-3 studies (DISCOVER-1 and -2).

This treatment represents a new therapeutic option for patients with active psoriatic arthritis, demonstrating both efficacy and safety, and it is the first selective IL-23 inhibitor to receive FDA approval for this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Guselkumab: the First Selective IL-23 Inhibitor for Active Psoriatic Arthritis in Adults. Boehncke, WH., Brembilla, NC., Nissen, MJ.[2021]

In the phase 3b COSMOS trial, guselkumab, an IL-23 inhibitor, was effective in reducing disease activity in adults with active psoriatic arthritis who had inadequate responses to tumor necrosis factor inhibitors, showing significant decreases in inflammatory markers like CRP and IL-17 levels by Week 24.

Participants treated with guselkumab exhibited a notable improvement in clinical response, with higher baseline levels of IL-22 and IFNɣ associated with better outcomes, indicating a potential biomarker for treatment efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of guselkumab on serum biomarkers in patients with active psoriatic arthritis and inadequate response to tumor necrosis factor inhibitors: results from the COSMOS phase 3b study. Schett, G., Chen, W., Gao, S., et al.[2023]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Guselkumab: First Global Approval. [2019]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Guselkumab: A Review in Moderate to Severe Plaque Psoriasis. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Efficacy and safety of guselkumab in patients with active psoriatic arthritis: a randomised, double-blind, placebo-controlled, phase 2 study. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Efficacy and safety of guselkumab in patients with active psoriatic arthritis who are inadequate responders to tumour necrosis factor inhibitors: results through one year of a phase IIIb, randomised, controlled study (COSMOS). [2022]

5. England pubmed.ncbi.nlm.nih.gov

Impact of guselkumab, an interleukin-23 p19 subunit inhibitor, on enthesitis and dactylitis in patients with moderate to severe psoriatic arthritis: results from a randomised, placebo-controlled, phase II study. [2021]

6. Canada pubmed.ncbi.nlm.nih.gov

Safety of Guselkumab With and Without Prior Tumor Necrosis Factor Inhibitor Treatment: Pooled Results Across 4 Studies in Patients With Psoriatic Arthritis. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Guselkumab safely improved clinical outcomes in biologic-naive patients with psoriatic arthritis. [2020]

8. England pubmed.ncbi.nlm.nih.gov

Guselkumab: the First Selective IL-23 Inhibitor for Active Psoriatic Arthritis in Adults. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Effect of guselkumab on serum biomarkers in patients with active psoriatic arthritis and inadequate response to tumor necrosis factor inhibitors: results from the COSMOS phase 3b study. [2023]